Atlas

Form 483

Agroindustria La Colosal del Centro SPR de RL Form 483, 2018-06-07

FDA issued a Form 483 to Agroindustria La Colosal del Centro SPR de RL on 2018-06-07 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Agroindustria La Colosal del Centro SPR de RL · Calvillo, Mexico · Issued June 7, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Jun 2018
21 CFR 114.80(a)(1)

Scheduled process

Cited by Sheri L Stephenson, Nicole L Kornspan

7 Jun 2018
21 CFR 114.83

Scheduled process establishment

Cited by Sheri L Stephenson, Nicole L Kornspan

7 Jun 2018
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Sheri L Stephenson, Nicole L Kornspan

Inspected site

ALAgroindustria La Colosal del Centro SPR de RLCalvillo, Mexico

Inspection team

SLSheri L Stephenson
NLNicole L Kornspan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere